HPVPro Study: Comparison of HPV Detection in Clinician-collected Cervical Swabs and Self-sampled Cervicovaginal Swabs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,044
- 试验地点
- 3
- 主要终点
- HPV prevalence
研究概览
简要总结
Comparison of the detection of human papillomavirus DNA in paired physician-obtained cervical swabs and self-sampled cervicovaginal swabs and evaluation of HPV prevalence in Czech women screening population.
详细描述
The cervical screening program in the Czech Republic is based on cytology with HPV triage. Nevertheless, cytology-based cervical screening may switch to HPV-based cervical screening in future. The implementation of primary HPV screening and insuficiency cervical screening attendance are a major challenge. The offering of self-sampling to the cervical screening non-attenders could increase women's participation as was shown in several European countries. The objective of the HPVPro study was to find out the HPV prevalence in the screening population of Czech women since there are no data for the Czech Republic. The second objective was to compare HPV DNA detection rate in paired self-sampled cervicovaginal swabs and physician-obtained cervical swabs and to determine acceptability of self-sampling HPV DNA test by Czech women. This information is important for optimisation of cervical cancer screening program in the Czech Republic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with age 30-64 years.
- •Women attending cervical cancer screening program in Czech Republic.
- •Women with completed informed consent.
排除标准
- •Pregnant women.
- •Women with no sexual intercourse experience.
- •Women after cervical conization or hysterectomy.
- •Women with CIN or cervical carcinoma in anamnesis.
- •Women at risk of increased bleeding.
结局指标
主要结局
HPV prevalence
时间窗: 18 months
Evaluation of the prevalence of high-risk human papillomavirus infection in screening population of Czech women.
Concordance of HPV positivity in self-collected cervicovaginal swabs and clinician-collected cervical swabs
时间窗: 18 months
Paired cervical and cervicovaginal swabs will be collected in the same day and will be tested by the same method. Concordance of HPV positivity in both swabs will be evaluated.
次要结局
- Comparison of different human papillomavirus DNA detection methods in cervical and cervicovaginal swabs.(18 months)